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Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD

ADPKD Clinical Trial

Official title:
A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease

Clinical Trial Summary

The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD).

Clinical Trial Description

Safety and efficacy of 50 mg tesevatinib in comparison to placebo in participants with ADPKD was assessed. The primary purpose of this study was focused on evaluating the change from Baseline in height-adjusted total kidney volume (htTKV) as measured by magnetic resonance imaging (MRI) at Months 12, 18, and 24, and 30 days post-dose in participants with ADPKD treated with tesevatinib or placebo. If eligible for the study participation, participants were randomly assigned to either investigational treatment group or placebo group. Treatment group received 50 mg tesevatinib once daily for 24 months and control group received the placebo once daily for 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03203642
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date October 12, 2017
Completion date January 25, 2022
View Details
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